MAUDE Adverse Event Report: HAMILTON MEDICAL, INC. HAMILTON VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

Event Type  Injury  

Event Description

Ventilator stopped working while connected to the patient and was not ventilating the patient.Ventilator was plugged into appropriate electrical outlet.Fda safety report id # (b)(4).

• Brand Name: HAMILTON VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): HAMILTON MEDICAL, INC.
• MDR Report Key: 10553097
• MDR Text Key: 207727370
• Report Number: MW5096730
• Device Sequence Number: 1
• Product Code: CBK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR
• Patient Weight: 142